Definition
QC management includes establishing ranges, monitoring shifts and trends, and linking corrective actions to instrument maintenance records.
Workflow
Workflows route failed QC to supervisors, optionally block patient reporting for affected assays, and document repeat QC acceptance.
Implementation
Rollouts should validate lot changes after reagent switches and recalibration events with defined signatories.
Compliance
ISO 15189 and CAP checklists expect demonstrable QC review; software assists but does not replace SOP adherence.